HARDYDISK IMIPENEM, 10MCG

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which are meant to represent the human form. ## JAN 1 8 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Melissa M. Traylor, RAC Director of Technical Services/Regulatory Affairs Hardy Diagnostics 1430 West McCoy Lane Santa Maria, California 93455 Re: K994132 Trade Name: HardyDisk™ Imipenem 10mcg Regulatory Class: II Product Code: JTN Dated: December 7, 1999 Received: December 7, 1999 Dear Ms. Traylor: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely yours. Steven Butman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/4 description: The image shows the logo for Hardy Diagnostics. The logo consists of a circular graphic on the left and the text "HARDY DIAGNOSTICS" on the right. The circular graphic is a black circle with several white lines running through it. The text is in a bold, sans-serif font, with "HARDY" on top and "DIAGNOSTICS" below. Email: Sales@Hardydiagnostics.com Website: Hardydiagnostics.com 430 Wirer Ader Salt Lake Chy, Uran 254 W. Commge Five Surkly. UT 84173 Tel: (800) 995 4:173 Fax. 9011562.3.14 Pliveritx, Arizona 355 W. Iron Ave., 8:05 Mesa, AZ 852 10 Tel: 1800) 995 8:56 Fax: (602) 464-9128 ## 510K Number: K994132 ## Indications for Use Use Statement-HardyDisk (4) Imipenem 10mcg HardyDisk™ Imipenem Antimicrobial Sensitivity Disks are used for scmi-quantitative in vitro susceptibility testing py the agar diffusion test procedure (Kirby-Baucr) of rapidly growing and certain tastidious bacterial pathogens. Standardized methods for agar diffusion testing have becn described list Enterobacteriaceae, Staphylococcus spp., Pscudomonus spp., Acinetobacter spp., Enterneonesus spp. other streptococci and, by modified procedures, Haemophilus influenzac, and Streptococcus pneumonine. <End> Concurence of CDRH-ODE Woody Dubois Devices O(k) Number Prescription Use (per 21 CFR 801. 109) OR Over-the Counter-Use (Optional formal 1-2-96) ## Serving dir. hal as assumist: VIRE 1987